US8075940B2 - Bioactive material coating method and tube - Google Patents

Bioactive material coating method and tube Download PDF

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Publication number
US8075940B2
US8075940B2 US12/866,235 US86623509A US8075940B2 US 8075940 B2 US8075940 B2 US 8075940B2 US 86623509 A US86623509 A US 86623509A US 8075940 B2 US8075940 B2 US 8075940B2
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United States
Prior art keywords
bioactive material
medication
tube
solvent
coating
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
US12/866,235
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English (en)
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US20110029069A1 (en
Inventor
Dae-Joong Kim
In-Su Baek
Jong-Sang Park
Hye-Yeong Nam
Chengzhe Bai
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Samsung Life Public Welfare Foundation
Sungkyunkwan University Foundation for Corporate Collaboration
Original Assignee
Samsung Life Public Welfare Foundation
Sungkyunkwan University Foundation for Corporate Collaboration
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Publication date
Application filed by Samsung Life Public Welfare Foundation, Sungkyunkwan University Foundation for Corporate Collaboration filed Critical Samsung Life Public Welfare Foundation
Assigned to SUNGKYUNKWAN UNIVERSITY FOUNDATION FOR CORPORATE COLLABORATION, SAMSUNG LIFE WELFARE FOUNDATION reassignment SUNGKYUNKWAN UNIVERSITY FOUNDATION FOR CORPORATE COLLABORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BAEK, IN-SU, BAI, CHENGZHE, KIM, DAE-JOONG, NAM, HYE-YEONG, PARK, JONG-SANG
Publication of US20110029069A1 publication Critical patent/US20110029069A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D35/00—Filtering devices having features not specifically covered by groups B01D24/00 - B01D33/00, or for applications not specifically covered by groups B01D24/00 - B01D33/00; Auxiliary devices for filtration; Filter housing constructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/02—Methods for coating medical devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3655—Arterio-venous shunts or fistulae
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2201/00—Details relating to filtering apparatus
    • B01D2201/31—Other construction details

Definitions

  • the present invention relates to a method for coating bioactive material and a structured coated with a bioactive material.
  • the e-PTFE is a thin film having fine pores.
  • the e-PTFE is produced as PTFE is expanded in various directions by being extruded at a high temperature and a high pressure. Since the e-PTFE has a small frictional coefficient, it can delay the adsorption of protein when contacting the blood. That is, since the e-PTFE has an anti-thrombosis quality, it is used as a material for creating an artificial blood vessel.
  • an artificial blood vessel connects an artery and a vein of a hemodialysis patient.
  • a particular portion of the human body needs to be incised by a hypodermic portion and then the artery and vein are perforated. After that, the perforated artery and vein are connected to both ends of an artificial blood vessel.
  • the connected artificial blood vessel is sutured in the incised portion and serves as a blood path to take hemodialysis, together with capillary connecting the arteries and the veins.
  • the artificial blood vessel is connected with an injector from a hemodialyzer, so that the hemodialyzer is located between the artery and the vein.
  • a patient uses his blood vessel as an artificial blood vessel.
  • his or her blood vessels may be diseased, it is difficult to use it as it is, so an artificial path is established between the artery and the vein.
  • an artificial blood vessel as the artificial path has been established, neointimal hyperplasia occurs in the portion of connection between the artery and the artificial blood vessel and between the vein and the artificial blood vessel.
  • an edema forms at the connection portion or the blood vessels are strangulated, so that the artificial blood vessel cannot function as a path. Therefore, a new artificial blood vessel is needed to reduce the strangulation of blood vessels and the development of inflammation.
  • the implanted artificial blood vessel implanted to patients is tightly connected with its surrounding tissues, the patient can easily receive hemodialysis treatment. Otherwise, bleeding may occur at the site of the artificial blood vessel after hemodialysis treatment. Therefore, the implanted artificial blood vessel is required to be fixed to its surrounding tissues as the size of the myofibroblast increases.
  • an artificial blood vessel, coated with paclitaxel used as an anticancer drug can remarkably reduce the strangulation of blood vessels and the occurrence of inflammation, compared with an artificial blood vessel that is not coated with medication, it is still disadvantageous as it cannot suppress the increase of myofibroblast.
  • the present invention solves the above problems, and provides a method that coats medication on artificial blood vessels to suppress the occurrence of strangulation in the artificial blood vessels and in the anastomosis of arteries and veins, and the inflammation of surrounding tissues, allowing the myofibroblast to increase.
  • the present invention further provides artificial blood vessels coated with medication.
  • a bioactive material coating method including: flowing a coating solution, produced as a bioactive material is dissolved in a mixed solvent, inside a structure having a lumen; and coating the bioactive material on at least one of inner and outer surfaces of the structure, with different concentrations.
  • the mixed solvent is mixed with two or more solvents having different features.
  • the structure connects both ends to the circulation paths of a human body.
  • the circulation paths of a human body are the blood vessels.
  • the blood vessels are an artery and a vein used as a blood vessel approach path of a hemodialysis patient.
  • one of the two or more solvents having different features is a polar solvent and another is a nonpolar solvent.
  • the polar solvent is water and the nonpolar solvent is acetone.
  • the bioactive material is a medication for suppressing neointimal hyperplasia.
  • the bioactive material is a paclitaxel.
  • the structure is a thin film of extended polytetrafluoroethylene (e-PTFE) having fine pores.
  • e-PTFE extended polytetrafluoroethylene
  • a tube wherein a bioactive material is coated on at least one of inner and outer surfaces of a structure having a lumen, with different concentrations, in which the structure connects both ends to the circulation paths of a human body.
  • the circulation paths of a human body are the blood vessels.
  • the blood vessels are an artery and a vein used as a blood vessel approach path of a hemodialysis patient.
  • the bioactive material is a medication for suppressing neointimal hyperplasia.
  • the bioactive material is a paclitaxel.
  • the structure is a thin film of extended polytetrafluoroethylene (e-PTFE) having fine pores.
  • e-PTFE extended polytetrafluoroethylene
  • the medication coating method coats medication on only the inner surface, contacting the blood, of the arteriovenous tube serving as an artificial blood vessel, thereby suppressing the occurrence of strangulation in blood vessels, inflammation, and thrombus, and the generation of new blood vessels.
  • the increase of the myofibroblast is not suppressed outside the tube because the medication is not coated on the outer surface of the tube, which does not contact the blood.
  • FIG. 1 is a view where an arteriovenous tube connects an artery and a vein of a hemodialysis patient;
  • FIG. 2 is a cross sectional view illustrating an arteriovenous tube, whose inner surface is coated with medication according to an embodiment of the present invention.
  • the present invention provides a method for coating a bioactive material on a structure having a lumen.
  • a structure having a lumen where the structure connects the artery and the vein to serve as a blood vessel approach path.
  • a lumen is the inner space of a tubular structure, such as an artery or intestine.
  • a structure with a lumen will be generally referred to as a tube.
  • the structure with a lumen i.e., a tube, is used to connect arteries and veins of a hemodialysis patient as shown in FIG. 1 .
  • the strangulation of blood vessels or the inflammation may occur around the arteriovenous tube.
  • medication a bioactive material, needs to be coated on only the inner wall of the arteriovenous tube.
  • the medication serves to suppress neointimal hyperplasia or thrombosis in the blood vessel. That is, since the inside of the arteriovenous tube directly contacts the blood, it needs to be coated with the medication. On the contrary, the medication is not coated on the outside of the arteriovenous tube to help increase the size of a myofibroblast.
  • the medication is dissolved in a polar solvent and then the solution flows through an arteriovenous tube, the medication is only coated with only the inner wall of the arteriovenous tube. Since the arteriovenous tube is made of an extended polytetrafluoroethylene (e-PTFE), it allows for the permeation of a nonpolar solvent, such as an acetone, but not a polar solvent, such as water.
  • e-PTFE extended polytetrafluoroethylene
  • a nonpolar solvent such as an acetone.
  • the polarity of the solvent is raised using a polar solvent. That is, a coating solution is made in such a way that a polar solvent and a nonpolar solvent are mixed with each other at a certain ratio to make a mixed solvent having a proper polarity and then the medication is dissolved in the mixed solvent.
  • the coating solution in which the medication is dissolved flows through the inside of the arteriovenous tube, it soaks into the arteriovenous tube so that the medication coats the inner wall of the arteriovenous tube.
  • the embodiment of the present invention uses an acetone as a nonpolar solvent, it should be understood, however, that the present invention is not limited to the embodiment.
  • the solvents may also use diethyl ether, ethyl acetate, dichloromethane, n-hexane, and chloroform, according to the solubility of medication.
  • the nonpolar solvent employs a solvent, such as an acetone, which has a high volatility and can easily dissolve the medication.
  • the arteriovenous tube is made of an e-PTFE.
  • the e-PTFE is an elastic fiber material.
  • the coating solution flows through the arteriovenous tube, it can easily soak into the arteriovenous tube if the ratio of the nonpolar solvent is higher than the ratio of the polar solvent.
  • the ratio of the nonpolar solvent is much higher than the ratio of the polar solvent, the coating solution may ooze out through the fine pores of the arteriovenous tube. Therefore, it is important to adjust the polarity during the preparation of the coating solution.
  • the polar solvent is water
  • the nonpolar solvent is an acetone
  • the medication is paclitaxel used as an anticancer drug.
  • the ratio of the acetone to water is 9:1, 8:2 or 7:3. If the ratio of water is much lower than the ratio of acetone, the coating solution is almost nonpolar. In that case, the coating solution may deeply permeate into the inner wall of the arteriovenous tube, so that a relatively large amount of medication coats the inside of the arteriovenous tube. On the contrary, if the ratio of water is much higher than the ratio of acetone, the coating solution has a high polarity. In that case, the coating solution may slightly permeate into the inner wall of the arteriovenous tube, so that a relatively small amount of medication coats the inside of the arteriovenous tube.
  • the embodiment of the present invention employs paclitaxel as a medication, it should be understood, however, that the present invention is not limited to the embodiment.
  • the present invention may use any mediation provided that they can suppress the strangulation of blood vessels or the occurrence of inflammation, for example, rapamycin, taclorimus, cyclosporine A, etc.
  • the e-PTFE since the e-PTFE is made of a fiber material, it may be expanded according to the pressure of the coating solution flowing through the arteriovenous tube. If the pressure of the coating solution is too high, the coating solution may ooze out through the fine pores of the arteriovenous tube. Therefore, the pressure of the coating solution needs to be properly controlled in the arteriovenous tube. It is preferable to use a peristaltic pump so that the coating solution flows through the arteriovenous tube at a proper pressure. The peristaltic pump can control the flow speed and flow time of the coating solution.
  • the concentration of the medication to be coated on the inside of the arteriovenous tube can also be controlled.
  • the slower the flow speed of the coating solution and the longer the flow time of the coating solution the higher the concentration of the medication to be coated on the inside of the arteriovenous tube.
  • the arteriovenous tube according to the present invention does not suppress the increase of the myofibroblast and is tightly fixed to its surrounding tissues.
  • arteriovenous tube according to an embodiment of the present invention has explained based on the use for the hemodialysis patients, it should be understood that it can used as an artificial blood vessel for connecting arteries and veins and also be connected to lymphatic vessels.
  • the arteriovenous tube according to the present invention can be used as an artificial blood vessel connecting the blood vessels or an artificial lymphatic vessel connecting lymphatic vessels.
  • the arteriovenous tube can be used for diseases, such as Critical Limb Ischemia. It can also be used as a replacement blood vessel, such as Coronary Artery Bypass Graft (CABG), as well as a blood vessel approach path.
  • CABG Coronary Artery Bypass Graft
  • the present invention can be widely applied to the medical technology sector.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Dermatology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Dispersion Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • External Artificial Organs (AREA)
  • Prostheses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
US12/866,235 2009-01-15 2009-01-19 Bioactive material coating method and tube Expired - Fee Related US8075940B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR1020090003472A KR101034654B1 (ko) 2009-01-15 2009-01-15 바이오액티브 물질 코팅방법
KR10-2009-0003472 2009-01-15
PCT/KR2009/000282 WO2010082698A1 (ko) 2009-01-15 2009-01-19 바이오액티브 물질코팅방법 및 튜브

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US20110029069A1 US20110029069A1 (en) 2011-02-03
US8075940B2 true US8075940B2 (en) 2011-12-13

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US (1) US8075940B2 (ko)
EP (1) EP2450068B1 (ko)
JP (1) JP5255656B2 (ko)
KR (1) KR101034654B1 (ko)
CN (1) CN101951971B (ko)
WO (1) WO2010082698A1 (ko)

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CN102125470B (zh) * 2011-01-30 2016-01-06 王嘉贤 支架型血管及将其植入人体的专用牵引工具
WO2014010759A1 (ko) * 2012-07-10 2014-01-16 주식회사 엠아이텍 인체에 삽입되는 루멘을 가진 원통형의 구조물
CN104027844A (zh) * 2014-04-04 2014-09-10 张志辉 一种用黄芪多糖涂层人工血管的新方法
CN104096265B (zh) * 2014-07-01 2016-03-23 温州医科大学 一种用于构建人工血管模型的三维收缩模型的制备方法
KR101812101B1 (ko) * 2016-10-10 2017-12-26 (주)메디파마플랜 인공혈관 내부 코팅장치
CN108947380B (zh) * 2017-05-18 2021-02-12 京畿大学校产学协力团 使用多孔材料固定化菌剂和近中性粘结剂用于细菌粘液基涂覆材料的制造方法
KR102283339B1 (ko) * 2019-06-27 2021-08-02 사회복지법인 삼성생명공익재단 생리활성물질이 코팅된 체내 이식용 인공혈관 및 그 코팅방법

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Also Published As

Publication number Publication date
EP2450068A1 (en) 2012-05-09
CN101951971B (zh) 2015-05-13
JP5255656B2 (ja) 2013-08-07
EP2450068A4 (en) 2013-12-25
JP2011509163A (ja) 2011-03-24
KR20100084059A (ko) 2010-07-23
KR101034654B1 (ko) 2011-05-16
CN101951971A (zh) 2011-01-19
WO2010082698A1 (ko) 2010-07-22
EP2450068B1 (en) 2020-03-04
US20110029069A1 (en) 2011-02-03

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